FDA Device recall Z-1135-2016
Product 37 consists of all product under product code: HSB and same usage: Item no: 225302055 INTERLOCKING IM SCREW LG 225303055 INTERLOCKI…
- FDA Device
- Class II
- terminated
- Published 2016-03-23
On 2016-03-23 the FDA classified a Class II recall of Product 37 consists of all product under product code: HSB and same usage: Item no: 225302055 INTERLOCKING IM SCREW LG 225303055 INTERLOCKI… by Zimmer Manufacturing B V, citing as a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1135-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-01-11 |
| Published | 2016-03-23 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Manufacturing B V |
| Distribution | US |
Product
Product 37 consists of all product under product code: HSB and same usage: Item no: 225302055 INTERLOCKING IM SCREW LG 225303055 INTERLOCKING IM SCREW LG 225304055 INTERLOCKING IM SCREW LG 225304555 INTERLOCKING IM SCREW LG 225305055 INTERLOCKING IM SCREW LG 225305555 INTERLOCKING IM SCREW LG 225306055 INTERLOCKING IM SCREW LG 225306555 INTERLOCKING IM SCREW LG 225307055 INTERLOCKING IM SCREW LG 225307555 INTERLOCKING IM SCREW LG 225308055 INTERLOCKING IM SCREW LG 225308555 INTERLOCKING IM SCREW LG 225309055 INTERLOCKING IM SCREW LG 225302542 INTERLOCKING IM SCREW MED 225303042 INTERLOCKING IM SCREW MED 225303542 INTERLOCKING IM SCREW MED 225304042 INTERLOCKING IM SCREW MED 225304542 INTERLOCKING IM SCREW MED 225305042 INTERLOCKING IM SCREW MED 225305542 INTERLOCKING IM SCREW MED 225306042 INTERLOCKING IM SCREW MED 225306542 INTERLOCKING IM SCREW MED 225307042 INTERLOCKING IM SCREW MED 225307542 INTERLOCKING IM SCREW MED 225308042 INTERLOCKING IM SCREW MED 225308542 INTERLOCKING IM SCREW MED 225302037 INTERLOCKING IM SCREW SML 225302537 INTERLOCKING IM SCREW SML 225303037 INTERLOCKING IM SCREW SML 225303537 INTERLOCKING IM SCREW SML 225304037 INTERLOCKING IM SCREW SML 225304537 INTERLOCKING IM SCREW SML 225305037 INTERLOCKING IM SCREW SML 225305537 INTERLOCKING IM SCREW SML 225306037 INTERLOCKING IM SCREW SML 225306537 INTERLOCKING IM SCREW SML 225308537 INTERLOCKING IM SCREW SML Product Usage: An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.
Reason
As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
Identifiers
| code_info | lot no.: 61906265 61764344 61764345 61763538 61804376 61804377 61804378 61809821 61843699 61889644 61912613…lot no.: 61906265 61764344 61764345 61763538 61804376 61804377 61804378 61809821 61843699 61889644 61912613 61920742 61934239 61934254 61934264 61934275 61968078 61983673 62005552 62021122 62038732 62165487 62165488 62188649 62188650 62253382 62253386 61709145 61763552 61763553 61804388 61841501 61881343 61889662 61912626 61920743 61934285 61934286 61934287 61934288 61993619 62005554 62021123 62038746 62121122 62121123 62176083 62176084 62188636 62253396 62253398 62298584 61809822 61821684 61839142 61876353 61876354 61876355 61876356 61878893 61889664 61908098 61908099 61908101 61908103 61968079 61968080 61979092 62027386 62027387 62027388 62027389 62075773 62075774 62075775 62075776 62075781 62075782 62075785 62075786 62075792 62075803 62075804 62075805 62075806 62075807 62121136 62121139 62121141 62121146 62188652 62188654 62188655 62188658 62188659 62188661 62188662 62188663 62262078 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1135-2016%22
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