FDA Device recall Z-1001-2014
Magna-Fx Cannulated Screw Fixation System 7.0 mm
- FDA Device
- Class II
- terminated
- Published 2014-02-26
On 2014-02-26 the FDA classified a Class II recall of Magna-Fx Cannulated Screw Fixation System 7.0 mm by Zimmer, citing zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was deter….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1001-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-10-11 |
| Published | 2014-02-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Zimmer |
| Distribution | US |
Product
Magna-Fx Cannulated Screw Fixation System 7.0 mm. Item codes starting with 0011420, 11460 and 11461.
Reason
Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.
Identifiers
| code_info | 60678937 60725698 60820102 60868357 61099266 61122455 61286984 60356456 60780951 60962055 61041381 61099267…60678937 60725698 60820102 60868357 61099266 61122455 61286984 60356456 60780951 60962055 61041381 61099267 61115876 61197682 60101457 60165562 60207649 60218165 60678939 60714704 60780952 60868358 60932395 61010681 61013650 61107937 61185828 61261813 60154179 60242174 60392816 60714705 60735829 60820103 60861042 60914270 60962060 61030191 61031913 61099268 61107952 61129838 61286986 62311946 60116999 60137567 60264359 60392817 60686417 60735830 60962064 61107953 61144212 61291484 62326539 60137568 60381037 60452034 60678940 60725699 60861044 60885486 61030192 61064420 61107954 61144213 61291485 61627268 62320020 60099553 60124830 60155276 60210916 60279193 60293173 60406084 60678941 60735831 60772796 60820105 60914273 60932397 60962068 61100754 61107955 61141540 61383124 61542613 60099554 60123327 60151759 60165563 60186810 60218909 60323277 60337989 60392818 60641792 60700524 60776686 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1001-2014%22
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