Severity
Moderate
FDA Devices recall · Reported September 3, 2014
Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, mu…
Zimmer, Inc. recalled Trauma Large Screws: CANN BONE SCREW 7.0MMX100MMLG CANN BONE SCREW 7.0X105LG CANN BONE… - a moderate-severity action.
Trauma Large Screws: CANN BONE SCREW 7.0MMX100MMLG CANN BONE SCREW 7.0X105LG CANN BONE… was recalled by Zimmer, Inc. in September 3, 2014. Reason: Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configuration…. Check the official notice for the remedy. Verify recall #Z-2549-2014 with the FDA Devices before acting.
The recall
Zimmer, Inc. issued this moderate-severity FDA Devices recall-Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configuration….
Sourced from official FDA Devices enforcement records. Verify recall #Z-2549-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-2549-2014) was formally reported on September 3, 2014, with the manufacturer initiating the action on July 22, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Zimmer, Inc. is listed as the recalling firm, operating out of Warsaw, IN. Federal records list the affected scope as 972,125 units, a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the si… Distribution data in the federal record shows the product reached: Worldwide Distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
972,125 units
Related Recalls
6
3 from same agency
Trauma Large Screws: CANN BONE SCREW 7.0MMX100MMLG CANN BONE SCREW 7.0X105LG CANN BONE SCREW 7.0X105LG CANN BONE SCREW 7.0MMX105MMLG CANN BONE SCREW 7.0X110LG CANN BONE SCREW 7.0X110LG CANN BONE SCREW 7.0MMX110MMLG CANN BONE SCREW 7.0X115LG CANN BONE SCREW 7.0X115LG CANN BONE SCREW 7.0MMX115MMLG CANN BONE SCREW 7.0X120LG CANN BONE SCREW 7.0X120LG CANN BONE SCREW 7.0MMX120MMLG CANN BONE SCREW 7.0X125LG CANN BONE SCREW 7.0MMX125MMLG CANN BONE SCREW 7.0X130LG CANN BONE SCREW 7.0MMX130MMLG RECON SCR LGE 5.5MMDX105MM RECON SCR LGE 5.5MMDX110MM RECON SCR LGE 5.5MMDX115MM RECON SCR LGE 5.5MMDX120MM RECON SCR LGE 5.5MMDX125MM RECON SCR LGE 5.5MMDX130MM ITST ANTI-ROT SCR 6.5MMDX105MM ITST ANTI-ROT SCR 6.5MMDX110MM PERI. SCR 3.5MM X105MML PERI SCR. 6.5MM X 100MM L PERI SCR. 6.5MM X 140MM L PERI SCR. 6.5MM X 100MM L PERI SCR. 6.5MM X 100MM L 3.5MM CORT SCR X 105MM SELFTAP 3.5MM CORT SCR X 110MM SELFTAP 5.5MM X 100MM CANN LKNG SCREW Z NAIL 6.0 X 105 CANC SCREW PT Z NAIL 6.0 X 110 CANC SCREW PT Z NAIL 6.0 X 115 CANC SCREW PT Z NAIL 6.0 X 120 CANC SCREW PT Z NAIL 6.0 X 125 CANC SCREW PT Z NAIL 6.0 X 130 CANC SCREW PT Z NAIL 6.0 X 135 CANC SCREW PT Z NAIL 6.0 X 140 CANC SCREW PT Z NAIL 6.0 X 105 CANC SCREW FA Z NAIL 6.0 X 110 CANC SCREW FA Z NAIL 6.0 X 115 CANC SCREW FA Z NAIL 6.0 X 120 CANC SCREW FA Z NAIL 6.0 X 125 CANC SCREW FA Z NAIL 6.0 X 130 CANC SCREW FA Z NAIL 6.0 X 135 CANC SCREW FA Z NAIL 6.0 X 140 CANC SCREW FA Z NAIL 6.0 X 105 CANC SCREW PT Z NAIL 6.0 X 110 CANC SCREW PT Z NAIL 6.0 X 115 CANC SCREW PT Z NAIL 6.0 X 120 CANC SCREW PT Z NAIL 6.0 X 125 CANC SCREW PT Z NAIL 6.0 X 130 CANC SCREW PT Z NAIL 6.0 X 135 CANC SCREW PT Z NAIL 6.0 X 140 CANC SCREW PT Z NAIL 6.0 X 105 CANC SCREW FA Z NAIL 6.0 X 110 CANC SCREW FA Z NAIL 6.0 X 115CANC SCREW FA Z NAIL 6.0 X 120CANC SCREW FA Z NAIL 6.0 X 125 CANC SCREW FA Z NAIL 6.0 X 130 CANC SCREW FA Z NAIL 6.0 X 135 CANC SCREW FA Z NAIL 6.0 X 140 CANC SCREW FA 3.5X105 CORT SCR 3.5 X 105 CORT SCR SELF TAP 3.5X110 CORT SCR 3.5 X 110 CORT SCR SELF TAP 3.5X115 CORT SCR 3.5 X 115 CORT SCR SELF TAP 3.5X120 CORT SCR 3.5 X 120 CORT SCR SELF TAP 3.5X125 CORT SCR 3.5X130 CORT SCR 3.5X135 CORT SCR 3.5X140 CORT SCR 3.5X145 CORT SCR 3.5X150 CORT SCR 4.5 X 105 CORT SCR SELF TAP 4.5 X 110 CORT SCR SELF TAP 4.5 X 120 CORT SCR SELF TAP 6.5X105 CANC SCR, FULLY THDED 6.5X105 CANC SCR, 16MM THD 6.5X105 CANC SCR, 32MM THD 6.5X110 CANC SCR, FULLY THDED 6.5X110 CANC SCR, 16MM THD 6.5X110 CANC SCR, 32MM THD 6.5X115 CANC SCR, 32MM THD 6.5X120 CANC SCR, 32MM THD
Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2549-2014 |
| Date reported | September 3, 2014 |
| Date initiated | July 22, 2014 |
| Recalling firm | Zimmer, Inc. |
| Firm location | Warsaw, IN |
| Affected scope | 972,125 units |
| Distribution | Worldwide Distribution. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 3, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.