Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported June 5, 2013
Tibial baseplate,cemented,#1 2203-3010 Tibial baseplate,cemented,#2 2203-3020 Tibial baseplate,cemented,#3 2203-3030 Tibial baseplate,cemented,#4 2203-3040 Tibial baseplate, cemented, #5 2203-3050 Tibial baseplate, cemented, #6 2203-3060 Tibial insert,CR,plained,#1,9mm 2303-1211 Tibial insert,CR,plained,#1,11mm 2303-1212 Tibial insert,CR,plained,#1,13mm 2303-1213 Tibial insert,CR,plained,#1,15mm 2303-1214 Tibial insert,CR,plained,#1,18mm 2303-1215 Tibial insert,CR,plained,#2,9mm 2303-
The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were …
The recall
Orthopedic Alliance LLC issued this moderate-severity FDA Devices recall — The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic….
- Moderate
- severity level
- 459 units
- units affected
- Class II
- classification
- June 5, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1379-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1379-2013) was formally reported on June 5, 2013, with the manufacturer initiating the action on February 20, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Orthopedic Alliance LLC is listed as the recalling firm, operating out of Murrieta, CA. Federal records indicate 459 units units are affected.
The documented reason for this recall is: The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician a… Distribution data in the federal record shows the product reached: Nationwide Distribution including the states of CA, MD, TX, NV, and WI.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC and NHTSA going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 13 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Where this recall sits in the database
Of 83,949 recalls in the database, 21,198 are high severity, 58,883 moderate, and 3,868 low. This recall is classified moderate severity.
Units Affected
459 units
Related Recalls
6
6 from same agency
Product Description
Tibial baseplate,cemented,#1 2203-3010 Tibial baseplate,cemented,#2 2203-3020 Tibial baseplate,cemented,#3 2203-3030 Tibial baseplate,cemented,#4 2203-3040 Tibial baseplate, cemented, #5 2203-3050 Tibial baseplate, cemented, #6 2203-3060 Tibial insert,CR,plained,#1,9mm 2303-1211 Tibial insert,CR,plained,#1,11mm 2303-1212 Tibial insert,CR,plained,#1,13mm 2303-1213 Tibial insert,CR,plained,#1,15mm 2303-1214 Tibial insert,CR,plained,#1,18mm 2303-1215 Tibial insert,CR,plained,#2,9mm 2303-1221 Tibial insert,CR,plained,#2,11mm 2303-1222 Tibial insert,CR,plained,#2,13mm 2303-1223 Tibial insert,CR,plained,#2,15mm 2303-1224 Tibial insert,CR,plained,#2,18mm 2303-1225 Tibial insert,CR,plained,#3,9mm 2303-1231 Tibial insert,CR,plained,#3,11mm 2303-1232 Tibial insert,CR,plained,#3,13mm 2303-1233 Tibial insert,CR,plained,#3,15mm 2303-1234 Tibial insert,CR,plained,#3,18mm 2303-1235 Tibial insert,CR,plained,#4,9mm 2303-1241 Tibial insert,CR,plained,#4,11mm 2303-1242 Tibial insert,CR,plained,#4,13mm 2303-1243 Tibial insert,CR,plained,#4,15mm 2303-1244 Tibial insert,CR,plained,#4,18mm 2303-1245 Tibial insert,CR,plained,#5,9mm 2303-1251 Tibial insert,CR,plained,#5,11mm 2303-1252 Tibial insert,CR,plained,#5,13mm 2303-1253 Tibial insert,CR,plained,#5,15mm 2303-1254 Tibial insert,CR,plained,#5,18mm 2303-1255 Tibial insert,CR,plained,#6,9mm 2303-1261 Tibial insert,CR,plained,#6,11mm 2303-1262 Tibial insert,CR,plained,#6,13mm 2303-1263 Tibial insert,CR,plained,#6,15mm 2303-1264 Tibial insert,CR,plained,#6,18mm 2303-1265 Tibial insert, PS , #1, 9mm 2303-3011 Tibial insert, PS , #1, 11mm 2303-3012 Tibial insert, PS , #1, 13mm 2303-3013 Tibial insert, PS , #1, 15mm 2303-3014 Tibial insert, PS , #1, 18mm 2303-3015 Tibial insert, PS , #2, 9mm 2303-3021 Tibial insert, PS , #2, 11mm 2303-3022 Tibial insert, PS , #2, 13mm 2303-3023 Tibial insert, PS , #2, 15mm 2303-3024 Tibial insert, PS , #2, 18mm 2303-3025 Tibial insert, PS , #3, 9mm 2303-3031 Tibial insert, PS , #3, 11mm 2303-3032 Tibial insert, PS , #3, 13mm 2303-3033 Tibial insert, PS , #3, 15mm 2303-3034 Tibial insert, PS , #3, 18mm 2303-3035 Tibial insert, PS , #4, 9mm 2303-3041 Tibial insert, PS , #4, 11mm 2303-3042 Tibial insert, PS , #4, 13mm 2303-3043 Tibial insert, PS , #4, 15mm 2303-3044 Tibial insert, PS , #4, 18mm 2303-3045 Tibial insert, PS , #5, 9mm 2303-3051 Tibial insert, PS , #5, 11mm 2303-3052 Tibial insert, PS , #5, 13mm 2303-3053 Tibial insert, PS , #5, 15mm 2303-3054 Tibial insert, PS , #5, 18mm 2303-3055 Tibial insert, PS , #6, 9mm 2303-3061 Tibial insert, PS , #6, 11mm 2303-3062 Tibial insert, PS , #6, 13mm 2303-3063 Tibial insert, PS , #6, 15mm 2303-3064 Tibial insert, PS , #6, 18mm 2303-3065 Variety of hip and knee implants and instruments, multiple uses.
Reason for Recall
The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
Details
- Recalling Firm
- Orthopedic Alliance LLC
- Units Affected
- 459 units
- Distribution
- Nationwide Distribution including the states of CA, MD, TX, NV, and WI.
- Location
- Murrieta, CA
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1379-2013 |
| Date reported | June 5, 2013 |
| Date initiated | February 20, 2013 |
| Recalling firm | Orthopedic Alliance LLC |
| Units affected | 459 units |
| Distribution | Nationwide Distribution including the states of CA, MD, TX, NV, and WI. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
Tibial baseplate,cemented,#1 2203-3010 Tibial baseplate,cemented,#2 2203-3020 Tibial baseplate,cemented,#3 2203-3030 Tibial baseplate,cemented,#4 2203-3040 Tibial baseplate, cemented, #5 2203-3050 Tibial baseplate, cemented, #6 2203-3060 Tibial insert,CR,plained,#1,9mm 2303-1211 Tibial insert,CR,plained,#1,11mm 2303-1212 Tibial insert,CR,plained,#1,13mm 2303-1213 Tibial insert,CR,plained,#1,15mm 2303-1214 Tibial insert,CR,plained,#1,18mm 2303-1215 Tibial insert,CR,plained,#2,9mm 2303-1221 Tibial insert,CR,plained,#2,11mm 2303-1222 Tibial insert,CR,plained,#2,13mm 2303-1223 Tibial insert,CR,plained,#2,15mm 2303-1224 Tibial insert,CR,plained,#2,18mm 2303-1225 Tibial insert,CR,plained,#3,9mm 2303-1231 Tibial insert,CR,plained,#3,11mm 2303-1232 Tibial insert,CR,plained,#3,13mm 2303-1233 Tibial insert,CR,plained,#3,15mm 2303-1234 Tibial insert,CR,plained,#3,18mm 2303-1235 Tibial insert,CR,plained,#4,9mm 2303-1241 Tibial insert,CR,plained,#4,11mm 2303-1242 Tibial insert,CR,plained,#4,13mm 2303-1243 Tibial insert,CR,plained,#4,15mm 2303-1244 Tibial insert,CR,plained,#4,18mm 2303-1245 Tibial insert,CR,plained,#5,9mm 2303-1251 Tibial insert,CR,plained,#5,11mm 2303-1252 Tibial insert,CR,plained,#5,13mm 2303-1253 Tibial insert,CR,plained,#5,15mm 2303-1254 Tibial insert,CR,plained,#5,18mm 2303-1255 Tibial insert,CR,plained,#6,9mm 2303-1261 Tibial insert,CR,plained,#6,11mm 2303-1262 Tibial insert,CR,plained,#6,13mm 2303-1263 Tibial insert,CR,plained,#6,15mm 2303-1264 Tibial insert,CR,plained,#6,18mm 2303-1265 Tibial insert, PS , #1, 9mm 2303-3011 Tibial insert, PS , #1, 11mm 2303-3012 Tibial insert, PS , #1, 13mm 2303-3013 Tibial insert, PS , #1, 15mm 2303-3014 Tibial insert, PS , #1, 18mm 2303-3015 Tibial insert, PS , #2, 9mm 2303-3021 Tibial insert, PS , #2, 11mm 2303-3022 Tibial insert, PS , #2, 13mm 2303-3023 Tibial insert, PS , #2, 15mm 2303-3024 Tibial insert, PS , #2, 18mm 2303-3025 Tibial insert, PS , #3, 9mm 2303-3031 Tibial insert, PS , #3, 11mm 2303-3032 Tibial insert, PS , #3, 13mm 2303-3033 Tibial insert, PS , #3, 15mm 2303-3034 Tibial insert, PS , #3, 18mm 2303-3035 Tibial insert, PS , #4, 9mm 2303-3041 Tibial insert, PS , #4, 11mm 2303-3042 Tibial insert, PS , #4, 13mm 2303-3043 Tibial insert, PS , #4, 15mm 2303-3044 Tibial insert, PS , #4, 18mm 2303-3045 Tibial insert, PS , #5, 9mm 2303-3051 Tibial insert, PS , #5, 11mm 2303-3052 Tibial insert, PS , #5, 13mm 2303-3053 Tibial insert, PS , #5, 15mm 2303-3054 Tibial insert, PS , #5, 18mm 2303-3055 Tibial insert, PS , #6, 9mm 2303-3061 Tibial insert, PS , #6, 11mm 2303-3062 Tibial insert, PS , #6, 13mm 2303-3063 Tibial insert, PS , #6, 15mm 2303-3064 Tibial insert, PS , #6, 18mm 2303-3065 Variety of hip and knee implants and instruments, multiple uses.. Recalled by Orthopedic Alliance LLC. Units affected: 459 units.
Why was this product recalled? ▼
The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 5, 2013. Severity: Moderate. Recall number: Z-1379-2013.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution including the states of CA, MD, TX, NV, and WI..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1379-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported June 5, 2013.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
Source: Federal recall agencies (FDA, CPSC, NHTSA) Aggregated federal recall feeds Recall data normalized across FDA, CPSC and NHTSA feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type).