Z-1388-2011

S-ROM Distal Femoral Cutting block Guide SZ X- SM/SM, REF 216311001, non-sterile, Depuy International Leeds...

Name: Z-1388-2011 S-ROM Distal Femoral Cutting block Guide SZ X- SM/SM, REF 216311001, non-sterile, Depuy International Leeds...
Creator: Depuy Orthopaedics, Inc.
Published: 2010-10-19
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2010-10-19 / Terminated / root cause: design

FDA source

Depuy Orthopaedics, Inc. began a recall of S-ROM Distal Femoral Cutting block Guide SZ X- SM/SM, REF 216311001, non-sterile, Depuy International Leeds, England. The product is used to make cuts in the... on 2010-10-19. The reason FDA records is "The firm was notified that the Hinge Block Femoral Box Guide cut being off alignment when using the S-ROM Distal Femoral Cutting Block Guide SZ SML/X-SML pin holes to locate. The firm then found that the same issue was...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1388-2011
Status: Terminated
Initiated: 2010-10-19
Posted: 2011-02-22
Terminated: 2012-12-03
Recalling firm: Depuy Orthopaedics Inc.
Product: S-ROM Distal Femoral Cutting block Guide SZ X- SM/SM, REF 216311001, non-sterile, Depuy International Leeds, England. The product is used to make cuts in the femur to prepare the femur for total knee replacement surgery.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: The firm was notified that the Hinge Block Femoral Box Guide cut being off alignment when using the S-ROM Distal Femoral Cutting Block Guide SZ SML/X-SML pin holes to locate. The firm then found that the same issue was found int the MED block size.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, DePuy, sent an "URGENT INFORMATION - DEVICE CORRECTION" email and letter dated October 19, 2010 to all customers. The notices described the product, problem and actions to be taken by the customers. The notices stated that: Depuy is issuing a device correction; however, the product may still be used; the devices do not need to be returned; the distributors were to provide a letter to clinicians that were using the device; the surgical technique will be revised in October 2010; the product will undergo a design change, and the recalled product will be traded out in December 2010 and January 2011. If you have any additional questions, please contact DePuy's Scientific Information office at 1-888-554-2482. On 3/4/2011, The firm sent out a revised URGENT DEVICE RECALL asking that all affected cutting guides be taken out of service immediately. Devices should be returned to DePuy and new cutting guides will be sent out within 2 weeks.
Quantity in commerce: 229
Distribution: Worldwide distribution: USA including states of: AZ, AR, CA, CO, FL, GA, IA, ID,IL, IN, KY, KS, LA, MA, MD, MI, MN, NC, NV, PA, TN, TX, VA, WA, and WI; and countries including: Canada and Ireland. Australia, Austria, Canada, Denmark, Ireland, Israel Italy, New Zealand, Russia, Sweden, Switzerland, Spain, and UK.
Product codes and lots: C44AJ4000, DG9K94000, DJ5EG4000, DJ5ER4000 and DJ5EW4000.

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)